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Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria

29 de maio de 2026 atualizado por: Hany Fathy Badawy, MD, Beni-Suef University

Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled Trial

Acute calculous anuria is a urological emergency caused by ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Urgent decompression of the upper urinary tract is required to restore urine drainage and prevent further renal impairment.

This prospective randomized double-blind controlled trial will evaluate whether intravesical aminophylline can facilitate urgent retrograde ureteral stenting in adult patients with acute calculous anuria due to ureteral stones. Eligible patients will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or placebo saline before attempted retrograde Double-J ureteral stent placement.

The primary outcome is technical success, defined as successful placement of a Double-J ureteral stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary outcomes include stenting time, intraoperative complications, renal function recovery, postoperative pain, analgesic requirement, and the need for alternative drainage.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This is a prospective, randomized, double-blind, controlled trial conducted at the Department of Urology, Beni-Suef University Hospital.

The study will include adult patients aged 18 years or older presenting with acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Obstruction will be confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract. Eligible patients will have clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and elevated serum creatinine.

After eligibility assessment and informed consent, participants will be randomly allocated in a 1:1 ratio to one of two groups.

Participants in the aminophylline group will receive intravesical instillation of 250 mg aminophylline diluted in normal saline to a total volume of 160 mL. Participants in the control group will receive placebo intravesical instillation using normal saline with the same total volume. The study solution will be prepared by a nurse who is not involved in the operation to maintain blinding of the patient and the operating surgeon.

Under general or spinal anesthesia, the patient will be placed in the lithotomy position. A cystoscope will be introduced and the bladder will be emptied. The assigned intravesical solution will then be instilled into the bladder and retained for 5 minutes before proceeding with retrograde ureteral stenting. Under fluoroscopic guidance, a guidewire will be advanced through the ureteric orifice in an attempt to bypass the obstructing ureteral stone. If successful, a Double-J ureteral stent will be advanced over the guidewire and positioned across the obstruction.

The primary endpoint is technical success of retrograde ureteral stenting, defined as successful placement of the Double-J stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary endpoints include time required for successful stent placement, intraoperative complications, serum creatinine changes at 24, 48, and 72 hours after decompression, postoperative pain score, analgesic requirement, and the need for alternative drainage after failed retrograde stenting.

Tipo de estudo

Intervencional

Inscrição (Estimado)

72

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Egito
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egito
        • Recrutamento
        • Department of Urology- Beni-Suef University Hospitals
        • Contato:
        • Contato:
        • Investigador principal:
          • Hany F Badawy, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Patients aged 18 years or older.
  2. Diagnosis of acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney.
  3. Obstruction confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract.
  4. Clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and serum creatinine >2 mg/dL.
  5. Ability to provide written informed consent.

Exclusion Criteria:

  1. Known hypersensitivity to aminophylline, theophylline, or other methylxanthines.
  2. Evidence of active urinary tract infection or urosepsis.
  3. Previous history of ureteral stricture or major urinary tract reconstructive surgery.
  4. Hemodynamic instability requiring immediate life-saving measures before urological intervention.
  5. Pregnancy.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intravesical Aminophylline
Participants will receive intravesical instillation of 250 mg aminophylline diluted with normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
Medicamento: Intravesical Aminophylline
Aminophylline 250 mg diluted with normal saline to a total intravesical instillation volume of 160 mL. The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
Comparador de Placebo: Placebo Saline
Participants will receive intravesical placebo instillation using normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
Medicamento: Placebo Saline
Placebo intravesical instillation using normal saline to a total volume of 160 mL. The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Technical Success of Retrograde Double-J Ureteral Stent Placement
Prazo: During the index urgent retrograde stenting procedure
Technical success will be defined as successful placement of a Double-J ureteral stent across the obstructing ureteral stone during the initial urgent retrograde stenting procedure without the need for percutaneous nephrostomy.
During the index urgent retrograde stenting procedure

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Retrograde Stenting Attempt Time
Prazo: During the index urgent retrograde stenting procedure
Time will be measured in minutes from the start of the retrograde stenting attempt after the 5-minute intravesical dwell time until successful final Double-J stent positioning or the decision to stop the retrograde attempt because of technical failure.
During the index urgent retrograde stenting procedure
Intraoperative Complication Rate
Prazo: During the index urgent retrograde stenting procedure
Proportion of participants who experience intraoperative procedure-related complications, including ureteral mucosal injury, ureteral perforation, bleeding, guidewire false passage, or other procedure-related adverse events.
During the index urgent retrograde stenting procedure
Serum Creatinine Change During the First 72 Hours After Decompression
Prazo: Baseline, 24 hours, 48 hours, and 72 hours after decompression
Serum creatinine will be measured before decompression and at 24, 48, and 72 hours after the procedure to assess early renal function recovery.
Baseline, 24 hours, 48 hours, and 72 hours after decompression
Postoperative Pain Score During the First 24 Hours
Prazo: Every 4 hours during the first 24 hours postoperatively
Postoperative pain will be assessed using a 10-point Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be recorded every 4 hours during the first 24 hours after recovery from anesthesia.
Every 4 hours during the first 24 hours postoperatively

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beni-Suef University

Investigadores

  • Investigador principal: Hany F Badawy, MD, Beni-Suef University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de abril de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de maio de 2026

Primeira postagem (Real)

1 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • FMBSUREC07042026Ahmed

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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